QA Specialist II - GMP/CGT Manufacturing

Beam Therapeutics; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Beam Therapeutics in North Carolina seeks a Specialist II, NC Product Quality Assurance to oversee GMP-compliant operations at the RTP facility, covering lab and manufacturing processes for clinical and upcoming commercial programs.

The role requires on-site presence with potential alternate shift schedules, coordinating with QA, manufacturing, QC, and facilities to ensure product quality and patient safety.

Qualifications

• Bachelor's or advanced degree in a scientific field with 3–4 years of pharmaceutical/biotech quality experience.
• Knowledge of aseptic processing and cell/gene therapy preferred.
• Excellent communication, attention to detail, and cross-functional collaboration.

Responsibilities

• Provide Quality oversight of on-the-floor manufacturing and QC testing.
• Review batch records, deviations, CAPAs, and product disposition.
• Support regulatory inspections and quality metrics.
• Assist with calibration, maintenance, and facility-related QA tasks.

Skills

Excellent communication skills

Attention to detail

Team collaboration

Problem solving

Education

Bachelor's or advanced degree in a scientific discipline

Job description

Beam Therapeutics in North Carolina seeks a Specialist II, NC Product Quality Assurance to oversee GMP-compliant operations at the RTP facility, covering lab and manufacturing processes for clinical and upcoming commercial programs.

The role requires on-site presence with potential alternate shift schedules, coordinating with QA, manufacturing, QC, and facilities to ensure product quality and patient safety.